QMS in a Box

Looking for a simple, yet effective QMS solution?

Are you a small medical device company in need of a lightweight, flexible and compliant QMS? AlvaMed’s QMS in a Box can be customized to suit your business needs and then installed rapidly to provide a right-sized QMS solution for most small medical device companies that need compliance with FDA, EU MDR and ISO 13485 quality system requirements.

If requested, AlvaMed can then help you manage and maintain your QMS until you are ready to bring it in house.

We meet with each client to understand their specific needs and objectives for their QMS. We leverage our extensive QMS experience to help ask the right questions.

We customize our QMS templates per client requests while ensuring compliance to the necessary regulatory requirements. Some clients may choose not to customize at all.

We will provide the full set of QMS documents to you and help you get the QMS up and running. We will help get your electronic filing system setup and your initial documents released through document control.

For customers who lack the resources or infrastructure, we can help you run and maintain your QMS as long as needed.

AlvaMed’s QMS in a Box provides efficient processes for compliance, while minimizing overhead burden.

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

Ready To Schedule A Call?

We look forward to discussing AlvaMed’s services with you.

QMS in a Box FAQ's

No, it is more like a paper-based QMS that is executed electronically. No paper is actually needed or generated.

Yes, AlvaMed’s QMS in a Box has been deployed at many companies that have resulted in successful audits and supported product approvals. We continually update our templates with client and regulator feedback, as well as best practice techniques.

Most startup and small companies want a QMS that is simple and flexible, can be deployed quickly and provide good value. The upfront and ongoing cost and complexities of many eQMS solutions make them less attractive by comparison.

Jon Saltonstall

Vice President of Regulatory and Quality Compliance

Jon and his team have helped multiple companies get their QMS up and running using AlvaMed’s QMS in a Box that has subsequently resulted in successful external audits and product submissions.

Ready to learn more about how AlvaMed’s QMS in a Box can help your company achieve its QMS goals?

Jon has many years of practical experience implementing and maintaining right-sized QMS solutions for startups and small companies. Schedule time to meet with Jon Saltonstall.